BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVAULTA SUPPORT SYSTEMS

    MDR report key: 2403703 · Received January 3, 2012

    Report

    Report Number
    MW5023725
    Event Type
    Other
    Date Received
    January 3, 2012
    Date of Event
    July 31, 2008
    Report Date
    January 3, 2012
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    POSTERIOR COLPORRHAPHY WAS PERFORMED WITH AN AVUALTA KIT. A DIFFERENT PHYSICIAN HAS NOW FOUND THAT THE MESH IS ERODING THROUGH THE PT'S VAGINA. EROSION WAS REPORTED TO FAMILY PHYSICIAN ON (B)(6) 2011. PT WAS SEEN BY GYNECOLOGIST TODAY (B)(6) 2012 TREATMENT WILL COMMENCE, BUT IS NOT FINALIZED. PORTION OF ERODED GRAFT REMOVED IN OFFICE TODAY. REASSESSMENT WILL BE DONE IN 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA SUPPORT SYSTEMS AVAULTA SUPPORT SYSTEMS FTL BARD MEDICAL DIVISION POSTERIOR KIT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other